Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077615
Company: APOTEX

Products on ANDA 077615

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 500MG VALPROIC ACID	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 250MG VALPROIC ACID	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
DIVALPROEX SODIUM	DIVALPROEX SODIUM	EQ 125MG VALPROIC ACID	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077615

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/29/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077615s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/18/2026	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
05/18/2026	SUPPL-24	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/18/2026	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
06/03/2024	SUPPL-22	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
07/31/2023	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
07/31/2023	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/31/2023	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
07/31/2023	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/27/2019	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/27/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
11/27/2019	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/27/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
11/27/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
11/27/2019	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
11/27/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
05/22/2015	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/22/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/22/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
05/22/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/16/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/16/2014	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
09/16/2014	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/21/2011	SUPPL-3	Labeling-Package Insert		Label is not available on this site.